Flaxseed Compared With Placebo in Patients With Hypercholesterolemia

Familial or Severe Hypercholesterolemia Clinical Trial

Official title:

A 4-week Study in Children and Adolescents With Familial or Severe Hypercholesterolemia Comparing Flaxseed Therapy to Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007344
• Other study ID #: 1000008297
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2009
• Last updated: August 25, 2013
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine if thirty grams per day of flaxseed consumption for 4 weeks could potentially reduce the serum lipid levels in children and adolescents with familial or severe hypercholesterolemia compared to those on placebo.

Description:

The proposed study is a 4 week randomized, double-blind, placebo-controlled clinical trial. Participants will be recruited from the pediatric lipid disorder clinic at the Hospital for Sick Children, which provides consultations to and management of children with primary lipid abnormalities. Patients that meet the study criteria will be approached during their routinely scheduled clinic visits, until the sample size (N=30) be reached. Patients will randomly be assigned to the intervention or the placebo group. The intervention group will be given muffins and breads containing ground flaxseed. Two muffins and one slice of bread will be consumed per day to provide a total of 30g flaxseed to the experimental group. The control group will be given muffins and breads containing whole wheat flour in place of flaxseed. Participants will be instructed to eat one muffin for breakfast, one muffin as an afternoon snack, and one slice of bread as an evening snack every day for a 4-week period. The muffins and breads use in the study will be baked by an independent baker.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• age 8 to 18 years

• positive first-degree family history of hypercholesterolemia or premature atherosclerotic cardiovascular disease

• elevated LDL level above 3.5 mmol/L and less than 5.0 mmol/L

• entered in the National Cholesterol Education Program Step II diet for at least 6 months

Exclusion Criteria:

• patients with secondary causes of hyperlipidemia

• history of major illness or surgery 3 months or less prior to enrollment

• taking lipid-lowering medications

• history of gastrointestinal problems

• allergies towards flaxseed

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Familial or Severe Hypercholesterolemia
• Hypercholesterolemia

Intervention

Dietary Supplement:
• flaxseed
1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks
• whole wheat flour
1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein		4 weeks	No
Secondary	LH (luteinizing hormone, FSH (follicle-stimulating hormone), DHEA-S (Dihydroepiandrosterone sulfate), free testosterone, androstenedione		4 weeks	No
Secondary	complete blood count		4 weeks	No